CDSCO Import License for Medical Devices

 

Medical Device Import License:

Applicable when we have to CDSCO Import License  from other countries to India. However they need to be classified according to CDSCO notified devices list. CDSCO has complete procedure for granting license for medical device imported in the countries.

Operon Strategist is a medical device consulting companies. we assists pharma or medical device distributors and medical device wholesalers in India to procure CDSCO import license. An Import license is issued for import of medical device from other country to India. Both the foreign company and Indian company jointly needs to submit the documentation for medical device and manufacturing unit.

Medical Device Registration for Import: - Medical Devices entering India must be in compliance with the Indian Medical Device Regulation set forth by the CDSCO. The CDSCO is responsible for the approval and regulation of New Drugs and Clinical Trials in the Country, laying down the standards for Drugs, control over the quality of imported drugs, coordination of the activity of State Drug Control Organizations.

CDSCO Import of medical devices in India Requirements:

• Form41 (Registration Certificate) is required as per requirements of the Drugs & Cosmetic Act.
• Wholesale Drug License in Form 20B & 21B.
• The firm must be registered with the CDSCO Sugam Online System.
• Cosmetics Registration.
• Import or Manufacture of drugs.
• Export NOC (Zone).
• Test License.
• Ethics Committee Registration.
• Formulation R&D Organization.
• Blood Bank Registration.
• Blood Product Registration.
• Dual Use NOC (Trader).
• BA/BE Approved Sites.
• Sponsors (BA/BE and CT).

Process for Obtaining CDSCO Import License:

For Obtaining an Import License in Form 10, an application in Form 8 and Form 9 is required. Since 1 April 2016, All Applications Should be made through the CDSCO’s Sugam Portal. For more information on the CDSCO’s – Portal for CDSCO Import License and Registration Certificate.

Read More - CDSCO Import License 

1. CDSCO Wholesale license Registration

2. CDSCO Manufacturing license

3. Medical Device Registration process in India

4. CDSCO classifications of medical devices

Contact details –

Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

1. Medical Device Consulting 
2. cdsco registration 
3. FDA 510k Clearance 
4. ce mark medical device 
5. CDSCO Manufacturing License 
6. CDSCO import license 
7. TURNKEY PROJECT CONSULTANT 
8. medical device manufacturing 
9. iso 15378 certification 
10. 21 cfr part 210 and 211 
11. ISO 13485 Medical Device Consultant 
12. Primary Packaging Turnkey Project Consultant 
13. Clean Room Design Consultant 
14. manufacturing site conceptualization 
15. Market Analysis and feasibility for Medical Devices 
16. manufacturing plant layout design 
17. medical device design and development 
18. DMF file submission guideline 
19. 21 cfr part 820 
20. qms certification services 
21. capa management 
22. design control requirements 
23. medical device process validation 
24. combination product 
25. continuous improvement program 
26. Medical Device Compliance & Regulatory Services 
27. Cdsco India authorized agent for medical device